| Product |
Company |
Generic name |
KEGG DRUG |
|
NORETHINDRONE tablet .35 mg (ANDA)
|
Mylan Pharmaceuticals Inc.
|
norethindrone
|
D00182
|
|
Albuterol Sulfate solution 2.5 mg/3mL (ANDA)
|
Mylan Pharmaceuticals Inc.
|
Albuterol Sulfate
|
D00683
|
|
Metronidazole gel 10 mg/g (ANDA)
|
Taro Pharmaceuticals U.S.A., Inc.
|
Metronidazole
|
D00409
|
|
Additive Formula 3 solution .03 g00mL (NDA)
|
Terumo BCT, Ltd
|
Dextrose Monohydrate, Trisodium Citrate Dihydrate, Sodium Chloride, Sodium Phosphate, Monobasic, Monohydrate, Citric Acid Monohydrate, and Adenine
|
|
|
OLOPATADINE HYDROCHLORIDE solution/ drops 2 mg/mL (ANDA)
|
Alembic Pharmaceuticals Inc.
|
olopatadine hydrochloride
|
D01192
|
|
Hydralazine Hydrochloride injection, solution 20 mg/mL (ANDA)
|
American Regent, Inc.
|
Hydralazine Hydrochloride
|
D01302
|
LOTRONEX tablet .5 mg (NDA)
LOTRONEX tablet 1 mg (NDA)
|
Sebela Pharmaceuticals Inc.
|
alosetron hydrochloride
|
D02829
|
|
Moxifloxacin Hydrochloride Tablets, 400 mg tablet, film coated 400 mg (ANDA)
|
Novadoz Pharmaceuticals LLC
|
Moxifloxacin Hydrochloride Tablets, 400 mg
|
D00874
|
|
Buspirone hydrochloride tablet 5 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC
|
Buspirone hydrochloride
|
D00702
|
|
Dicyclomine Hydrochloride capsule 10 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC
|
Dicyclomine Hydrochloride
|
D00717
|
|
RISPERIDONE tablet 2 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC
|
RISPERIDONE
|
D00426
|
Quetiapine fumarate tablet, film coated 50 mg (ANDA)
Quetiapine fumarate tablet, film coated 100 mg (ANDA)
Quetiapine fumarate tablet, film coated 200 mg (ANDA)
Quetiapine fumarate tablet, film coated 300 mg (ANDA)
Quetiapine fumarate tablet, film coated 400 mg (ANDA)
Quetiapine fumarate tablet, film coated 25 mg (ANDA)
Quetiapine fumarate tablet, film coated 150 mg (ANDA)
|
Dr.Reddy's Laboratories Limited
|
Quetiapine fumarate
|
D00458
|
|
ADSOL Red Cell Preservation Solution System in Plastic Container (PL 146 Plastic) kit (NDA)
|
Fenwal, Inc.
|
Anticoagulant Citrate Phosphate Dextrose (CPD) Solution and ADSOL Preservation Solution
|
|
|
levocetirizine dihydrochloride solution 2.5 mg/5mL (ANDA)
|
Camber Pharmaceuticals, Inc.
|
levocetirizine dihydrochloride
|
D08118
|
|
TIZANDINE tablet 2 mg (ANDA)
|
DirectRX
|
TIZANDINE
|
D00776
|
VITRAKVI capsule 25 mg (NDA)
VITRAKVI capsule 100 mg (NDA)
VITRAKVI solution 20 mg/mL (NDA)
|
Loxo Oncology, Inc.
|
LAROTRECTINIB
|
D11138
|
|
DIPHTHERIA AND TETANUS TOXOIDS ADSORBED injection, suspension 5 [Lf]/.5mL (BLA)
|
Sanofi Pasteur Inc.
|
CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) and CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)
|
|
Glycopyrrolate injection .2 mg/mL (ANDA)
Glycopyrrolate injection .4 mg/2mL (ANDA)
Glycopyrrolate injection 1 mg/5mL (ANDA)
Glycopyrrolate injection 4 mg/20mL (ANDA)
|
Caplin Steriles Limited
|
Glycopyrrolate
|
D00540
|
|
HYDRALAZINE HCL tablet, film coated 50 mg (ANDA)
|
DirectRX
|
HYDRALAZINE HCL
|
D01302
|
|
Ursodiol capsule 300 mg (ANDA)
|
PuraCap Laboratories, LLC
|
Ursodiol
|
D00734
|
Metformin Hydrochloride tablet, coated 500 mg (ANDA)
Metformin Hydrochloride tablet, coated 850 mg (ANDA)
Metformin Hydrochloride tablet, coated 1000 mg (ANDA)
|
TAGI Pharma, Inc.
|
Metformin Hydrochloride
|
D00944
|
|
Caffeine Citrate solution 20 mg/mL (ANDA)
|
Fresenius Kabi USA, LLC
|
CAFFEINE CITRATE
|
D07603
|
Amitriptyline Hydrochloride tablet, film coated 25 mg (ANDA)
Amitriptyline Hydrochloride tablet, film coated 50 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC
|
Amitriptyline Hydrochloride
|
D00809
|
|
Bupivacaine Hydrochloride with Dextrose injection 7.5 mg/mL (ANDA)
|
B. Braun Medical Inc.
|
Bupivacaine Hydrochloride with Dextrose
|
D01450
|
Buspirone Hydrochloride tablet 5 mg (ANDA)
Buspirone Hydrochloride tablet 7.5 mg (ANDA)
Buspirone Hydrochloride tablet 10 mg (ANDA)
Buspirone Hydrochloride tablet 15 mg (ANDA)
Buspirone Hydrochloride tablet 30 mg (ANDA)
|
Epic Pharma, LLC
|
Buspirone Hydrochloride
|
D00702
|
Levothyroxine Sodium injection, solution 20 ug/mL (NDA)
Levothyroxine Sodium injection, solution 40 ug/mL (NDA)
Levothyroxine Sodium injection, solution 100 ug/mL (NDA)
|
Fresenius Kabi USA, LLC
|
Levothyroxine Sodium
|
D11113
|
|
SSD Cream cream 10 g000g (NDA)
|
Dr Reddys Laboratories Inc
|
Silver Sulfadiazine
|
D00433
|
|
CLARITHROMYCIN tablet, film coated 500 mg (ANDA)
|
DirectRX
|
CLARITHROMYCIN
|
D00276
|
|
TRAZODONE HYDROCHLORIDE tablet 150 mg (ANDA)
|
DIRECT RX
|
TRAZODONE HYDROCHLORIDE
|
D00820
|
|
Glipizide tablet 5 mg (ANDA)
|
Lake Erie Medical DBA Quality Care Products LLC
|
Glipizide
|
D00335
|
|
VALACYCLOVIR tablet 500 mg (ANDA)
|
DirectRX
|
VALACYCLOVIR
|
D00398
|
|
SULINDAC tablet 200 mg (ANDA)
|
Lake Erie Medical DBA Quality Care Products LLC
|
SULINDAC
|
D00120
|
Methocarbamol tablet, coated 500 mg (ANDA)
METHOCARBAMOL tablet 750 mg (ANDA)
|
DirectRX
|
Methocarbamol
|
D00402
|
Hydrochlorothiazide tablet 25 mg (ANDA)
Hydrochlorothiazide tablet 50 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC
|
Hydrochlorothiazide
|
D00340
|
|
Risperidone tablet 2 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC
|
Risperidone
|
D00426
|
Atenolol tablet 25 mg (ANDA)
Atenolol tablet 100 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC
|
Atenolol
|
D00235
|
|
Hydrochlorothiazide tablet 25 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC
|
Hydrochlorothiazide
|
D00340
|
|
Sucralfate tablet 1 g (NDA AUTHORIZED GENERIC)
|
Aphena Pharma Solutions - Tennessee, LLC
|
Sucralfate
|
D00446
|
|
Verapamil Hydrochloride injection 2.5 mg/mL (ANDA)
|
Micro Labs Limited
|
Verapamil Hydrochloride
|
D00619
|
|
Losartan Potassium tablet, film coated 50 mg (ANDA)
|
Aphena Pharma Solutions - Tennessee, LLC
|
Losartan Potassium
|
D00357
|